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LAMOTRIGINE TEVA 200MG TABLETS

Active substance(s): LAMOTRIGINE / LAMOTRIGINE / LAMOTRIGINE

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TEVA UK Ref:

Version:

231-30-84100-ZC LEA LAMOTRIGINE TEVA A/S TAB TUK
Dim’s Changed?:
Length:
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No
323 mm
160 mm
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Colours Used:

6 July 2016

BLACK
PANTONE® GREEN C
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PAGE 1: FRONT FACE (INSIDE OF REEL)

Package leaflet:
information for the user
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
• If you get any of the side effects talk to your doctor or
pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Lamotrigine is and what it is used for
What you need to know before you take Lamotrigine
How to take Lamotrigine
Possible side effects
How to store Lamotrigine
Contents of the pack and other information

1

What Lamotrigine is and what it is used for

(Main)

Pharma code 446

Lamotrigine belongs to a group of medicines called
anti-epileptics. It is used to treat epilepsy.
Lamotrigine treats epilepsy by blocking the signals in the brain
that trigger epileptic seizures (fits).
• For adults and children aged 13 years and over, Lamotrigine
can be used on its own or with other medicines, to treat
epilepsy. Lamotrigine can also be used with other medicines to
treat the seizures that occur with a condition called
Lennox-Gastaut syndrome.
• For children aged between 2 and 12 years, Lamotrigine can be
used with other medicines, to treat those conditions. It can be
used on its own to treat a type of epilepsy called typical
absence seizures.

2

What you need to know before you take
Lamotrigine

Important information about potentially life-threatening
reactions
A small number of people taking Lamotrigine have experienced
an allergic reaction or potentially life-threatening skin reaction,
which may develop into more serious problems if they are not
treated. These can include Stevens–Johnson syndrome (SJS),
toxic epidermal necrolysis (TEN) and drug reaction with
eosinophilia and systemic symptoms (DRESS). You need to know
the symptoms to look out for while you are taking Lamotrigine.
Read the description of these symptoms in Section 4 of this
leaflet under ‘Potentially life-threatening reactions: get a doctor’s
help straight away’.
DO NOT take Lamotrigine:
• if you are allergic (hypersensitive) to lamotrigine or any of the
other ingredients of lamotrigine (listed in section 6).
If this applies to you, tell your doctor, and do not take
Lamotrigine.
Take special care with Lamotrigine
Warnings and precautions
Talk to your doctor or pharmacist before taking before you take
Lamotrigine if you:
• have problems with your kidneys
• have ever developed a rash when you’ve taken lamotrigine or
other medicines for epilepsy
• if you have ever developed meningitis after taking lamotrigine
(read the description of these symptoms in Section 4 of this
leaflet: Rare side effects)
• are already taking medicine that contains lamotrigine.
If any of these applies to you, tell your doctor, who may decide to
lower your dose, or that Lamotrigine is not suitable for you.
Watch out for important symptoms
If you develop a rash or these skin symptoms, stop taking
Lamotrigine, seek urgent advice from a doctor and tell him that
you are taking this medicine:
• Potentially life-threatening skin rashes (Stevens-Johnson
syndrome, toxic epidermal necrolysis or DRESS) have been
reported with the use of Lamotrigine, appearing initially as
reddish target-like spots or circular patches often with central
blisters on the trunk. For more information on these reactions,
please read section 4 (Possible side effects).
• Additional signs to look for include ulcers in the mouth, throat,
nose, genitals and conjunctivitis (red and swollen eyes).
• These potentially life-threatening skin rashes are often
accompanied by flu-like symptoms and a rash on the face then
an extended rash with a high temperature, increased levels of
liver enzymes seen in blood tests and an increase in a type of
white blood cell (eosinophilia) and enlarged lymph nodes. The
rash may progress to widespread blistering or peeling of the
skin.
• The highest risk for occurrence of serious skin reactions is
within the first weeks of treatment.
• If you have developed Stevens-Johnson syndrome, toxic
epidermal necrolysis or a drug reaction with eosinophilia and
systemic symptoms (DRESS) with the use of Lamotrigine, you
must not be re-started on Lamotrigine at any time.
• a high temperature (fever)
• drowsiness
These symptoms are more likely to happen during the first few
months of treatment with Lamotrigine, especially if you start on
too high a dose or if your dose is increased too quickly, or if
you’re taking Lamotrigine with another medicine called valproate.
Children are more likely to be affected than adults.
The symptoms listed above can develop into more serious
problems, such as organ failure or a very severe skin condition, if
they are not treated. If you notice any of these symptoms, see a
doctor as soon as possible. Your doctor may decide to carry out
tests on your liver, kidneys or blood, and may tell you to stop
taking Lamotrigine.

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Thoughts of harming yourself or suicide
If you have distressing thoughts or experiences, or if you notice
that you feel worse or develop new symptoms while you’re taking
Lamotrigine:
See a doctor as soon as possible or go to the nearest hospital for
help
A small number of people being treated with anti-epileptics such
as Lamotrigine have had thoughts of harming or killing
themselves. If at any time you have these thoughts, immediately
contact your doctor.
Risk of increased or severe seizures
The seizures in some types of epilepsy may occasionally become
worse or happen more often while you’re taking Lamotrigine.
Some patients may experience severe seizures, which may cause
serious health problems. If your seizures happen more often, or if
you experience a severe seizure while you’re taking Lamotrigine,
see a doctor as soon as possible.
Other medicines and Lamotrigine
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines including herbal
medicines or other medicines bought without a prescription.
• oxcarbazepine, felbamate, gabapentin, levetiracetam,
pregabalin, topiramate or zonisamide, used to treat epilepsy
• lithium, olanzapine or aripiprazole used to treat mental health
problems
• bupropion, used to treat mental health problems or to stop
smoking
If you start or stop taking certain medicines whilst you are taking
Lamotrigine, your doctor may need to check your dose of
Lamotrigine. These include:
• atazanavir in combination with ritonavir
• lopinavir in combination with ritonavir
Tell your doctor if you start or stop taking any of these.
Some medicines interact with Lamotrigine or make it more likely
that you’ll have side effects. These include:
• valproate, used to treat epilepsy and mental health problems
• carbamazepine, used to treat epilepsy and mental health
problems
• phenytoin, primidone or phenobarbital, used to treat epilepsy
• olanzapine, used to treat mental health problems
• risperidone, used to treat mental health problems
• rifampicin, which is an antibiotic
• a combination of lopinavir and ritonavir, used to treat Human
Immunodeficiency Virus (HIV) infection
• hormonal contraceptives, such as the Pill (see below).
Tell your doctor if you are taking, or if you start or stop taking, any
of these.
Hormonal contraceptives (such as the Pill) can affect the way
Lamotrigine works
• Your doctor may recommend that you use a particular type of
hormonal contraceptive, or another method of contraception,
such as condoms, a cap or a coil. If you are using a hormonal
contraceptive like the Pill, your doctor may take samples of
your blood to check the level of Lamotrigine. If you plan to start
using a hormonal contraceptive, talk to your doctor, who will
discuss suitable methods of contraception with you.
• Lamotrigine can also affect the way hormonal contraceptives
work, although it’s unlikely to make them less effective. If you
are using a hormonal contraceptive and you notice any
changes in your menstrual pattern, such as breakthrough
bleeding or spotting between periods, tell your doctor. These
may be signs that Lamotrigine is affecting the way your
contraceptive is working.
Pregnancy, breast-feeding and fertility
• If you are pregnant, think you may be pregnant or are planning
to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
• You should not stop treatment for your epilepsy while you’re
pregnant. However, there is an increased risk of birth defects
in babies whose mothers took Lamotrigine during pregnancy.
These defects include cleft lip or cleft palate. Your doctor may
advise you to take extra folic acid if you’re planning to become
pregnant and while you’re pregnant.
• Pregnancy may also alter the effectiveness of Lamotrigine, so
your doctor may take samples of your blood to check the level
of Lamotrigine, and may adjust your dose.
• Talk to your doctor or pharmacist if you are breast-feeding or
planning to breast-feed. The active ingredient of Lamotrigine
passes into breast milk and may affect your baby. Your doctor
will discuss the risks and benefits of breast feeding while
you’re taking Lamotrigine, and will check your baby from time
to time if you decide to breast feed.
Driving and using machines
• Lamotrigine can cause dizziness and double vision. Do not
drive or operate machines unless you are sure you’re not
affected.
If you have epilepsy, talk to your doctor about driving and using
machines.
Important information about some of the ingredients of
Lamotrigine
Lamotrigine tablets contain small amounts of a sugar called
lactose. If you have intolerance to lactose or any other sugars,
tell your doctor, and do not take Lamotrigine.
Lamotrigine 100 mg and 200 mg tablets also contain E110 (sunset
yellow FCF), which may cause allergic reactions.

3

How to take Lamotrigine

Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
How much Lamotrigine to take
It may take a while to find the best dose of Lamotrigine for you.
The dose you take will depend on:
• your age
• whether you are taking Lamotrigine with other medicines
• whether you have problems with your kidneys or liver.
Your doctor will start you on a low dose, and gradually increase
the dose over a few weeks until you reach a dose that works for
you (called the effective dose). Never take more Lamotrigine
than your doctor tells you to.

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Lamotrigine Teva 25 mg, 50 mg,
100 mg and 200 mg Tablets

TEVA UK Ref:

Version:

231-30-84100-ZC LEA LAMOTRIGINE TEVA A/S TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

1

Colours Used:

BLACK
PANTONE® GREEN C
Template

PAGE 2: REAR FACE (OUTSIDE OF REEL)

The recommended effective dose of Lamotrigine for adults and
children aged over 12 years is between 100 mg and 400 mg each
day.
For children aged 2 to 12 years, the effective dose depends on
their body weight — usually, it’s between 1 mg and 15 mg for each
kilogram of the child’s weight, up to a maximum of 400 mg daily.
Lamotrigine is not recommended for children aged under 2 years.
How to take your dose of Lamotrigine
Take your dose of Lamotrigine once or twice a day, as your doctor
advises. You can take it with or without food.
Your doctor may also advise you to start or stop taking other
medicines, depending on what condition you’re being treated for
and the way you respond to treatment.
• Swallow your tablets whole. Do not break, chew or crush them.
• Always take the full dose that your doctor has prescribed.
Never take only part of a tablet.
If you take more Lamotrigine than you should
If anyone takes too much Lamotrigine, contact a doctor or
pharmacist or go to the nearest emergency department
immediately. If possible, show them the Lamotrigine packet.
Someone who has taken too much Lamotrigine may have any of
these symptoms:
• rapid, uncontrollable eye movements (nystagmus)
• heart rhythm changes (detected usually on ECG)
• clumsiness and lack of co-ordination, affecting their balance
(ataxia)
• loss of consciousness, fits (convulsions) or coma.
If you forget to take Lamotrigine
Do not take extra tablets or a double dose to make up for a
forgotten dose. If you have missed taking a dose of this
medicine, just take your next dose at the usual time.
Ask your doctor for advice on how to start taking it again. It’s
important that you do this.
Do not stop taking Lamotrigine without advice
Take Lamotrigine for as long as your doctor recommends. Do not
stop unless your doctor advises you to.
To stop taking Lamotrigine, it is important that your dose is
reduced gradually, over about 2 weeks. If you suddenly stop
taking Lamotrigine, your epilepsy may come back or get worse.

Rare side effects
These may affect up to 1 in 1,000 people:
• life-threatening skin reaction (Stevens-Johnson syndrome
(SJS)): (see also the information at the beginning of Section 4)
• a group of symptoms together including: fever, nausea, vomiting,
headache, stiff neck and extreme sensitivity to bright light. This
may be caused by an inflammation of the membranes that cover
the brain and spinal cord (meningitis). These symptoms usually
disappear once treatment is stopped however if the symptoms
continue or get worse contact your doctor
• rapid, uncontrollable eye movements (nystagmus)
• itchy eyes, with discharge and crusty eyelids (conjunctivitis)
Very rare side effects
These may affect up to 1 in 10,000 people:
• a life-threatening skin reaction (toxic epidermal necrolysis):
see also the information at the beginning of Section 4
• Drug Reaction with Eosinophilia and Systemic Symptoms
(DRESS): (see also the information at the beginning of Section 4)
• a high temperature (fever): (see also the information at the
beginning of Section 4)
• swelling around the face (oedema) or swollen glands in the
neck, armpit or groin (lymphadenopathy): (see also the
information at the beginning of Section 4)
• changes in liver function, which will show up in blood tests, or
liver failure (see also the information at the beginning of
Section 4)
• changes which may show up in blood tests - including reduced
numbers of red blood cells (anaemia), reduced numbers of
white blood cells (leucopenia, neutropenia, agranulocytosis),
reduced numbers of platelets (thrombocytopenia), reduced
numbers of all these types of cell (pancytopenia) and a
disorder of the bone marrow called aplastic anaemia
• mbers of all these types of cell (pancytopenia) and a disorder
of the bone marrow called aplastic anaemia
• hallucinations (‘seeing’ or ‘hearing’ things that aren’t really
there)
• confusion
• feeling ‘wobbly’ or unsteady when you move about
• uncontrollable body movements (tics), uncontrollable muscle
spasms affecting the eyes, head and torso (choreoathetosis),
or other unusual body movements such as jerking, shaking or
stiffness
Possible side effects
• in people who already have epilepsy, seizures happening more
Like all medicines, this medicine can cause side effects, but not
often
everyone gets them.
• in people who already have Parkinson’s disease, worsening of
Potentially life-threatening reactions: get a doctor’s help
the symptoms
straight away
• lupus-like reaction (symptoms may include: back or joint pain
A small number of people taking Lamotrigine get an allergic
which sometimes may be accompanied by fever and/or
reaction or potentially serious skin reaction, which may develop
general ill health)
into more serious, and even life-threatening, problems if they are Frequency not known
not treated. Symptoms of these reactions include:
The frequency of these side effects cannot be estimated from the
• skin rashes or redness which may develop into
currently available data:
life-threatening skin reactions including widespread rash with
blisters and peeling skin, particularly occurring around the mouth, • There have been reports of bone disorders including
osteopenia and osteoporosis (thinning of the bone) and
nose, eyes and genitals (Stevens–Johnson syndrome (SJS)),
fractures. Check with your doctor or pharmacist if you are on
extensive peeling of the skin (more than 30% of the body surface
long-term antiepileptic medication, have a history of
– toxic epidermal necrolysis) or extended rashes with liver, blood
osteoporosis, or take steroids.
and other body organs involvement (Drug Reaction with

Nightmares
Eosinophilia and Systemic Symptoms which is also known as
Reporting of side effects:
DRESS hypersensitivity syndrome).
If you get any side effects, talk to your doctor or pharmacist . This
• a sore mouth or red or swollen eyes (conjunctivitis)
includes any possible side effects
• a high temperature (fever), flu-like symptoms or drowsiness
not listed in this leaflet. You can also report side effects directly
• swelling around your face, or swollen glands in your neck,
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
armpit or groin
By reporting side effects you can help provide more information
• unexpected bleeding or bruising, or your fingers turning blue
on the safety of this medicine
• a sore throat, or more infections (such as colds) than usual
• increased levels of liver enzymes seen in blood tests
How to store Lamotrigine
• an increase in a type of white blood cell (eosinophils)
• enlarged lymph nodes
Keep this medicine out of the sight and sight of children.
• involvement of the organs of the body including liver and
Do not store above 30°C. Store in the original blister pack to
kidneys.
protect from moisture.
In many cases, these symptoms will be signs of less serious side Do not use this medicine after the expiry date which is stated on
effects but you must be aware that they are potentially
the outer packaging. The expiry date refers to the last day of that
life-threatening and can develop more serious problems, such as month.
organ failure, if they are not treated. If you notice any of these
Do not throw away any medicines via wastewater or household
symptoms:
waste. Ask your pharmacist how to throw away medicines you no
• Contact a doctor immediately. Your doctor may decide to carry longer use. These measures will help to protect the environment.
out tests on your liver, kidneys or blood and may tell you to stop
taking Lamotrigine. In case you have developed
Contents of the pack and other information
Stevens-Johnson syndrome or toxic epidermal necrolysis your
What Lamotrigine Teva Tablets contain:
doctor will tell you that you must never use lamotrigine again
• The active ingredient is lamotrigine.
Potentially life-threatening skin rashes (Stevens-Johnson
• The other ingredients are lactose monohydrate,
syndrome, toxic epidermal necrolysis, or extended rashes with
microcrystalline cellulose, pregelatinised starch, povidone
liver, blood and other body organs involvement (DRESS)have been
K-30, colloidal anhydrous silica, sodium starch glycolate (Type
reported (see section 2).
A) and magnesium stearate. In addition, the 100 mg and 200 mg
These are very serious but rare or very rare side effects. You may
tablets contain sunset yellow FCF (E110) and the 200 mg tablets
need urgent medical attention or hospitalisation. In many cases,
contain indigo carmine (E132).
your symptoms will be signs of less serious side effects. But you
What Lamotrigine Teva Tablets look like and contents of the pack:
must be aware that they are potentially serious — so, if you
• Lamotrigine 25 mg tablets are white to off white, diamond
notice any of these symptoms, see a doctor as soon as possible.
shaped tablets, debossed with the number “93” on one side
Your doctor may decide to carry out tests on your liver, kidneys or
and scored between the two numbers, debossed “39” on the
blood, and may tell you to stop taking Lamotrigine.
other side.
• Lamotrigine 50 mg Tablets are white to off white, round shaped
Very common side effects
tablet, debossed with the number “50” on one side and
These may affect more than 1 in 10 people:
debossed “LT” on the other side.
• headache
• Lamotrigine 100 mg tablets are peach, diamond shaped tablets,
• skin rash.
debossed with the number “93” on one side and scored
Common side effects
between the two numbers, debossed “463” on the other side.
These may affect up to 1 in 10 people:
• Lamotrigine 200 mg tablets are blue, diamond shaped tablets,
• aggression or irritability
debossed with the number “93” on one side and scored
• shaking or tremors
between the two numbers, debossed “7248” on the other side.
• difficulty in sleeping (insomnia)
• Lamotrigine packs are blister packs of transparent or white
• feeling agitated
opaque PVC/PVDC-aluminium lidded with aluminium foil for 21,
• diarrhoea
21 calendar, 30, 42, 42 calendar, 56, 60, 90, or 100 tablets.
• dry mouth
Marketing Authorisation Holder and Manufacturer
• feeling tired
Marketing Authorisation holder and company responsible for
• pain in your back or joints, or elsewhere
manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
Uncommon side effects
This leaflet was last revised: July 2016
These may affect up to 1 in 100 people
• clumsiness and lack of co-ordination (ataxia)
PL00289/0496-0499
84100-ZC
• double vision or blurred vision
• unusual hair loss or thinning (alopecia)
160 x 323

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6 July 2016

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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